ObsEva's EDELWEISS Trial Hits All Goals In Endometriosis-associated Pain

(RTTNews) - ObsEva SA's (OBSV) phase 2b clinical trial of Linzagolix for the treatment of endometriosis-associated pain has achieved primary and secondary endpoints.

In the trial, dubbed EDELWEISS, patients were randomized to receive either an oral once daily dose of Linzagolix (50mg, 75mg, 100mg or 200mg) or placebo for up 12 weeks.

The primary endpoint of the EDELWEISS clinical trial was a responder analysis, with responses defined as a reduction of at least 30% in combined menstrual and non-menstrual pelvic pain, recorded daily and assessed via electronic diary over the last 28 days of treatment on a verbal rating scale.

According to the Company, the study primary endpoint was achieved for the three top doses, and patients receiving a 75mg dose had the highest responder rate of 61.5% compared to the placebo at 34.5%.

With respect to the menstrual pain verbal rating scale, i.e., the secondary endpoint, patients receiving a 200mg dose reported the highest responder rate at 78.9%, compared to a placebo responder rate of 28.5%.

Linzagolix was observed to be safe and well tolerated, added the Company.

The 24-week data, including the bone mineral density (BMD) assessment, from the EDELWEISS trial is expected to be available in the fourth quarter of 2018.

ObsEva intends to seek feedback from regulatory authorities on the design of a Phase 3 clinical trial program of Linzagolix for the treatment of endometriosis-associated pain by the end of 2018.

OBSV closed Friday's trading at $14.55, down 3.00%.